First-in-human Study of DRP-104 (Sirpiglenastat) as Single Agent and in Combination With Atezolizumab in Patients With Advanced Solid Tumors.
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- STATUS
- Recruiting
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- End date
- Dec 28, 2023
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- participants needed
- 246
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- sponsor
- Dracen Pharmaceuticals, Inc.
Summary
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmaco-dynamics and preliminary anti-tumor activity of DRP-104 (sirpiglenastat) administered via intravenous infusion or via subcutaneous injection as a single agent and in combination with atezolizumab in patients with advanced solid tumors and to assess preliminary safety and efficacy of which route of administration (intravenous or subcutaneous) will be selected for further development for the other two expansions of patients, advanced non-small cell lung cancer (NSCLC) with defined genetic mutations, and advanced squamous cell carcinoma of the head and neck (SCCHN).
Description
This study will be conducted in 4 Parts:
Part 1: Phase 1 single-agent dose escalation of DRP-104 (sirpiglenastat) in patients with advanced solid tumors to define the MTD (up to approximately 50 patients for each intravenous and subcutaneous cohort)
Part 2, Once the MTD of DRP-104 for the IV and subQ route of administration will be determined in Part 1, Part 2 will include 2 specific cohorts: Cohort 2 and 3 with one only selected formulation. Once the MTD of DRP-104 has been declared for either the IV or suQ cohort, Cohort 1 of Part 2 will separately expand for each cohort. -Cohort 1: Phase 1 single-agent safety expansion at the of DRP-104 in patients with advanced solid tumors (N= minimum of 14 and up to 20 patients for each intravenous and subcutaneous cohorts); The Sponsor will determine at completion of Phase 1 which route of administration will be further developed and continued for all subsequent Cohorts 2 and 3 and Parts 3 and Part 4 in combination with atezolizumab.
- Cohort 2: Phase 2a expansion at the of DRP-104 in patients with locally advanced or metastatic NSCLC whose tumors contain a KEAP1 mutation, NFE2L2 mutation and/or STK11 mutation (N=55 patients)
- Cohort 3: Phase 2a expansion at the MTD of DRP-104 in recurrent, unresectable or metastatic SCCHN (N=15-25 patients).
Part 3: Phase 1 combination dose escalation of DRP-104 (sirpiglenastat) (with either IV or subcutaneous formulation selected) and atezolizumab in patients with advanced solid tumors previously treated with an anti-PD-1, anti PD-L1, and/or anti-CTLA-4 antibody, starting one dose level below the MTD of single-agent DRP-104 and in combination with atezolizumab (up to approximately N=12 patients).
Part 4: Phase 1 combination safety expansion at the MTD of DRP-104 (with either IV or subcutaneous formulation selected)with atezolizumab in a similar patient population as the dose-escalation (N=14 patients).
Details
| Condition | Recurrent NSCLC, Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma of the Head and Neck, Squamous cell carcinoma, Non Small Cell Lung Cancer Metastatic, Squamous Cell Carcinoma, Advanced Solid Tumor, Recurrent Non-small Cell Lung Cancer, Advanced Malignant Solid Tumor, head and neck cancer, Non Small Cell Lung Cancer Recurrent, Head and Neck Cancer |
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| Treatment | Atezolizumab, DRP-104 |
| Clinical Study Identifier | NCT04471415 |
| Sponsor | Dracen Pharmaceuticals, Inc. |
| Last Modified on | 28 June 2021 |
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